Regional Medical Safety Officer - Consumer-00000ON5
Description
The Johnson & Johnson Group of Consumer Companies is recognised as a world leader in providing health and beauty products and solutions across Baby, Beauty, Healthcare and OTC medicines. The breadth and depth of our product portfolio is truly impressive and constantly expanding as we strive to bring science to the art of healthy livingTM.
Position Title: Regional Medical Safety Officer
Location: Maidenhead, UK or EMEA
Closing Date: 4th July 2014
Position Summary:
The Regional Medical Safety Officer (RMSO) reports into the Medical Safety Organization and works in collaboration with the MSO(s) who has global responsibilities for a therapy area to develop the strategy and oversee the execution of the risk management and pharmacovigilance activities for all products licensed/marketed in a region. The RMSO owns the post-marketing safety surveillance and risk management recommendations for allocated products of local responsibility (POLO) including provision of medical safety input into their labelling, collaborates with matrix teams from other J&J functions and licensing partners on assessment of safety issues, co-chairs SMTs for these products. The RMSO in alignment with relevant MSOs provides medical safety expert input into product development of regional products, aggregate safety data assessments including Health Hazard Evaluations of all products licensed/marketed in the region and any other products assigned by management. The RMSO, leads development of medical safety assessments of quality issues with potential impact on their safe use, and together and presents agreed with the MSO and SMT medical safety position at pre-QRBs and QRBs. The RMSO ensures communication of potential and known risks, when appropriate, to direct management, and personnel in all other relevant functional areas as per appropriate Company procedures.
Main duties and responsibilities:
• Develop surveillance programs for the allocated POLOs and oversee the conduct of all investigations of medical safety signals and issues through the product life cycle and in cooperation with other functional groups within the Medical Safety Organization and J&J as required
• Oversee the development of medical safety content of local risk management plans and risk mitigation strategies and approve final version of medical safety content of plans/strategies for allocated POLOs, provide input to the core management plans and oversee implementation of risk mitigation strategies on their territories
• Provide input into product development process and contribute to the design and interpretation of Clinical Investigations and non-Clinical Safety Studies for POLOs and regional products
• Lead in collaboration with MSO,SMT and Quality Assurance and Compliance management of GMP events with potential impact on safety
o Prepare Health Hazard Evaluations / Medical Safety Assessments for all products licensed/marketed in the region and other products assigned by management
o Represent Medical Safety position at pre-QRB and QRB meetings for all products within the scope their responsibility.
o Provide medical safety input to the local/regional Management Review Boards, including information on observed trends of AEs for products of their responsibility and ensure performing of relevant trending as needed
o Provide medical safety expertise to Quality and Compliance Organization with out of trend assessments and root cause analysis of non-conformances where appropriate
• For the POLOs under his/ her purview, co-chair the Safety Management Teams (SMT) together with the MSO responsible for the therapeutic area, which are product-based, cross-functional teams responsible for review, assessment, and evaluation of Medical Safety data arising from any source throughout the a product’s lifecycle. Responsibilities in this capacity include:
o Review available medical safety information from multiple sources and making timely decisions including risk mitigation recommendations and input into product risk management plans
o Ensure that SMT are in place for all products under their purview
o Ensure that SMT makes timely decisions on the medical safety of products in accordance with established policies and procedures and oversee their implementation
o Escalate issues as appropriate
• For products marketed/licensed in their regions and other products assigned to them by management:
o Provide medical safety input to the in maintenance of labeling safety information
o Represent the medical safety in CCDS Labeling Working Group
o Provide medical safety input to the questions from regulatory authorities
o Advise on the appropriate medical safety strategy for regulatory authority submissions of safety data and provide input into development of safety elements of the submissions as required by the regional regulatory
o Participate in SMT meetings chaired by the MSO responsible for the therapeutic area
o Escalate as appropriate to direct management and other functions safety signals, potential safety issues as per appropriate Company procedures
Qualifications
Key Qualifications, Experience and Skills required:
• Doctor of Medicine, (MD)
• Specialization in primary care medicine, public health, epidemiology, or related disciplines desirable
• Significant experience in clinical/pharmaceutical medicine including some experience in pharmacovigilance
• Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance
• Experience in risk evaluation and mitigation
• Able to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), and communicate and align stakeholders to safety decisions
• Good communication skills across all levels and functional areas
• Good skills for coaching, influencing and educating colleagues inside the Medical Safety organization and beyond
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your leadership experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Maidenhead
Other Locations:Europe/Middle East/Africa
Organization: J&J Consumer Services EMAE., Ltd (8675)
Job Function: Drug & Product Safety Science
Description
The Johnson & Johnson Group of Consumer Companies is recognised as a world leader in providing health and beauty products and solutions across Baby, Beauty, Healthcare and OTC medicines. The breadth and depth of our product portfolio is truly impressive and constantly expanding as we strive to bring science to the art of healthy livingTM.
Position Title: Regional Medical Safety Officer
Location: Maidenhead, UK or EMEA
Closing Date: 4th July 2014
Position Summary:
The Regional Medical Safety Officer (RMSO) reports into the Medical Safety Organization and works in collaboration with the MSO(s) who has global responsibilities for a therapy area to develop the strategy and oversee the execution of the risk management and pharmacovigilance activities for all products licensed/marketed in a region. The RMSO owns the post-marketing safety surveillance and risk management recommendations for allocated products of local responsibility (POLO) including provision of medical safety input into their labelling, collaborates with matrix teams from other J&J functions and licensing partners on assessment of safety issues, co-chairs SMTs for these products. The RMSO in alignment with relevant MSOs provides medical safety expert input into product development of regional products, aggregate safety data assessments including Health Hazard Evaluations of all products licensed/marketed in the region and any other products assigned by management. The RMSO, leads development of medical safety assessments of quality issues with potential impact on their safe use, and together and presents agreed with the MSO and SMT medical safety position at pre-QRBs and QRBs. The RMSO ensures communication of potential and known risks, when appropriate, to direct management, and personnel in all other relevant functional areas as per appropriate Company procedures.
Main duties and responsibilities:
• Develop surveillance programs for the allocated POLOs and oversee the conduct of all investigations of medical safety signals and issues through the product life cycle and in cooperation with other functional groups within the Medical Safety Organization and J&J as required
• Oversee the development of medical safety content of local risk management plans and risk mitigation strategies and approve final version of medical safety content of plans/strategies for allocated POLOs, provide input to the core management plans and oversee implementation of risk mitigation strategies on their territories
• Provide input into product development process and contribute to the design and interpretation of Clinical Investigations and non-Clinical Safety Studies for POLOs and regional products
• Lead in collaboration with MSO,SMT and Quality Assurance and Compliance management of GMP events with potential impact on safety
o Prepare Health Hazard Evaluations / Medical Safety Assessments for all products licensed/marketed in the region and other products assigned by management
o Represent Medical Safety position at pre-QRB and QRB meetings for all products within the scope their responsibility.
o Provide medical safety input to the local/regional Management Review Boards, including information on observed trends of AEs for products of their responsibility and ensure performing of relevant trending as needed
o Provide medical safety expertise to Quality and Compliance Organization with out of trend assessments and root cause analysis of non-conformances where appropriate
• For the POLOs under his/ her purview, co-chair the Safety Management Teams (SMT) together with the MSO responsible for the therapeutic area, which are product-based, cross-functional teams responsible for review, assessment, and evaluation of Medical Safety data arising from any source throughout the a product’s lifecycle. Responsibilities in this capacity include:
o Review available medical safety information from multiple sources and making timely decisions including risk mitigation recommendations and input into product risk management plans
o Ensure that SMT are in place for all products under their purview
o Ensure that SMT makes timely decisions on the medical safety of products in accordance with established policies and procedures and oversee their implementation
o Escalate issues as appropriate
• For products marketed/licensed in their regions and other products assigned to them by management:
o Provide medical safety input to the in maintenance of labeling safety information
o Represent the medical safety in CCDS Labeling Working Group
o Provide medical safety input to the questions from regulatory authorities
o Advise on the appropriate medical safety strategy for regulatory authority submissions of safety data and provide input into development of safety elements of the submissions as required by the regional regulatory
o Participate in SMT meetings chaired by the MSO responsible for the therapeutic area
o Escalate as appropriate to direct management and other functions safety signals, potential safety issues as per appropriate Company procedures
Qualifications
Key Qualifications, Experience and Skills required:
• Doctor of Medicine, (MD)
• Specialization in primary care medicine, public health, epidemiology, or related disciplines desirable
• Significant experience in clinical/pharmaceutical medicine including some experience in pharmacovigilance
• Demonstrated skills/knowledge of regulatory requirements for global pharmacovigilance
• Experience in risk evaluation and mitigation
• Able to critically evaluate safety data from multiple sources (clinical trials, environment, literature, etc), and communicate and align stakeholders to safety decisions
• Good communication skills across all levels and functional areas
• Good skills for coaching, influencing and educating colleagues inside the Medical Safety organization and beyond
What type of mark will you make? Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your leadership experience; express your passion and touch the world.
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We respectfully request Government Officials to identify themselves as such on application; for the purposes of the Foreign Corrupt Practices Act.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Maidenhead
Other Locations:Europe/Middle East/Africa
Organization: J&J Consumer Services EMAE., Ltd (8675)
Job Function: Drug & Product Safety Science